Calgene Fresh announced Tuesday that it has completed FDAsubmissions for public comment on its Flavr Savr tomato.

The subsidiary of Calgene Inc. (NASDAQ:CGNE) of Davis, Calif.,said the final submissions came in response to FDA questionsraised during review of information the company providedwith its Aug. 12, 1991, request for an advisory opinion.

Calgene Fresh on Jan. 5 asked the FDA to consider use of thekanamyacin-resistant marker as a food additive.

"They wanted to take the high road by going into the highest-level review possible," said Maureen McGann, an analyst withMerrill Lynch.

The most recent data come from company nutritional andsafety studies. A panel of nationally recognized food scientists,convened by the company, concluded the "MacGregor" tomatois safe.

"Flavr Savr tomatoes are as safe for human consumption asother tomatoes that are currently part of the human diet," saidIan Munro, a panel member and toxicology consultant, who wasdirector general for the Food Directorate in Canada'sDepartment of Health and Welfare.

"This is trailblazing activity with regard to the FDA because it isthe first genetically engineered plant to be sold as food," saidDavid Evans, vice president of business development at DNAPlant Technology Corp. (NASDAQ:DNAP) of Cinnaminson, N.J.,which is planning to launch its "Vinesweet" tomato, developedwithout genetic engineering, this summer.

DNAP created the variety through the cellular biologytechnique of somaclonal variation, but intends to later bring tomarket tomatoes that are genetically engineered to have longershelf-life and enhanced flavor through inhibition of the genethat leads to the onset of ripening.

Evans said the Industrial Biotechnology Association's policyrecommending food labeling for content, not process, shouldapply to these foods because gene engineering is "too broad"for the indication to be meaningful to consumers.

Ted Howard, executive director of the Pure Food Campaign, toldBioWorld that his organization is planning a consumer-orientedcampaign against Calgene's tomato in the marketplace, but willnot oppose it through the regulatory process.

The Pure Food Campaign wants labeling, safety testing andregistration of these foods, Howard said, to track them back totheir source in case a "mistake" creates potential problems."The government's view is these foods are no different thannaturally occurring foods," he said. "We disagree with that."

His group is planning a campaign for April and May aimed atconsumers in stores, and to organize boycott committees, hesaid, so a "whole environment of consumer opposition" willmeet the tomato's launch, expected in late summer or early fall.

"Given the history of the FDA on this whole issue," Howard said,"I think we're all anticipating the FDA will give approval. Nowthat (David) Kessler is continuing as head of the FDA, I thinkthe green light for genetically engineered food products will goon."

Indeed, McGann believes that investors may find agriculturalbiotechnology stocks attractive now because unlike companiesfocusing on pharmaceuticals, they have not been beaten downby fears of health care regulation. She also predicted that thedebut of the two tomatoes this summer "could generateexcitement for the whole ag biotech sector."

Calgene's stock closed Tuesday at $13.50 a share, down 13cents.

-- Nancy Garcia Associate Editor

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